FDA Adds New Eye Warning to Ozempic, Wegovy and Other Popular GLP-1 Drugs

A new eye risk warning will soon be added to GLP-1 drug labels. Here is a look at the warning and what prompted the concern.

FDA Announces New Warning for GLP-1 Drugs

The U.S. Food and Drug Administration (FDA) announced on Monday that it is requiring GLP-1 drugs to include a warning about the potential risk of a serious eye condition. The warning will soon appear on popular weight loss and diabetes drugs such as Eli Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Ozempic and Wegovy.

The nation's top health regulator said that it is requiring the drug makers to add this information to the "warnings and precautions" section of the products. The FDA said that the warnings will need to include information about the potential for an increased risk of a condition known as non-arteritic anterior ischemic optic neuropathy (NAION).

NAION is a common cause of sudden vision loss. While the condition is painless, it can lead to permanent impairment of eyesight in severe cases. The condition is triggered by a decreased amount of blood flow to the front area of the optic nerve. The underlying cause of NAION is not completely understood by medical professionals.

“Patients and caregivers should be aware of a potential increased risk of NAION, a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss,” explained the FDA in a news release.

The FDA said that it looked at a body of evaluated clinical trial data, as well as research on animals and post-marketing data to come to this determination. The agency also said that it evaluated observational studies and case reports before making the decision to require the warning label.

The agency confirmed that it started investigating the possibility of vision loss linked to the drugs following the results of a 2024 study published in JAMA Ophthalmology. Researchers in this study noted that diabetes patients prescribed semaglutide were four times as likely to exhibit NAION when compared to those not using this class of drugs.

The decision by the FDA comes after the European Medicines Agency’s (EMA) safety committee also noted last year that Wegovy and Ozempic may cause NAION in very rare cases. This was the first time that a governmental regulator had acknowledged this potential side effect.

The EMA said that NAION may impact up to 1 in 10,000 people using these drugs. The issue has been blamed on semaglutide, the active ingredient used in products such as Wegovy and Ozempic.

Four Danish patients who experienced vision loss from the use of Novo's GLP-1 drugs were awarded compensation.

Details of Past Research  

Past research backs up the claim. An expansive study published in 2025 looked at almost 175,000 patients being treated with semaglutide for diabetes and compared them to an equal number of diabetics taking non-GLP-1 medications. The study found that the risk of developing NAION more than doubled with the use of a GLP-1 drug for two years, compared to the use of diabetes medicines with different active ingredients.

What makes the link difficult to prove is that the risk factors for NAION often overlap with patients using GLP-1 drugs. For example, sufferers of sleep apnea, Type 2 diabetes, and hypertension are inherently at a higher risk of NAION.

According to the American Academy of Ophthalmology, NAION is the second most common optic nerve disease in the U.S. The condition affects up to 10 out of 10,000 Americans over the age of 50.

Patients are being advised to report any sudden loss or disturbance of vision to their healthcare provider immediately.

While the use of GLP-1s has been hailed as a breakthrough treatment for diabetes and obesity, the drugs do not come without risk. Novo Nordisk and Eli Lilly products carry warnings for kidney injury, gallbladder issues, and pancreatitis. These labels also include a black box warning about the potential threat of thyroid tumors.

Novo Nordisk and Eli Lilly both said that patient safety is their top priority.

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